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18 Years
40 Years
Not Enrolling
Polycystic Ovary Syndrome, Hyperinsulinism

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Trial Information

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study.
Patients are randomized to one of two treatment arms.

Patients receive oral metformin or oral placebo three times daily for 7 weeks. Patients
remaining anovulatory by day 49 receive metformin or placebo plus escalating doses of oral
clomiphene citrate daily for 5 consecutive days, beginning on days 50, 80, and 110.
Following ovulation, treatment with clomiphene citrate and metformin or placebo continues
until 6 ovulatory cycles occur, pregnancy occurs, or anovulation persists. Patients
receiving the placebo arm who have not ovulated on the highest dose of clomiphene citrate
may be crossed over to receive metformin after a 6 week washout.

Inclusion Criteria


--Disease Characteristics--

Patients with chronic anovulation due to polycystic ovary syndrome (PCOS) who have failed
clomiphene citrate

Must have oligoovulation and hyperandrogenemia

--Prior/Concurrent Therapy--

Endocrine therapy: At least 2 months since prior clomiphene citrate


- At least 2 months since prior standard therapy (including over the counter drugs)

- At least 2 months since prior investigational drugs

- Prior multi/prenatal vitamins allowed

--Patient Characteristics--

Hematopoietic: Hematocrit greater than 38%


- Liver function normal

- No clinically significant hepatic disease


- No clinically significant renal disease

- Creatinine less than 1.4 mg/dL

- No proteinuria

Cardiovascular: No clinically significant cardiac disease

Pulmonary: No clinically significant pulmonary disease


- Thyroid function normal

- Prolactin normal

- Estradiol normal

- Fasting 17 alpha-hydroxy progesterone less than 200 ng/dL OR No late onset adrenal
hyperplasia 21 alpha-hydroxylase deficiency


- Not pregnant

- Negative pregnancy test

- Male partner must have a normal semen analysis by WHO criteria

- Must be in acceptable health by interview, medical history, physical exam, and
laboratory tests

- No diabetes mellitus

- No clinically significant neurologic, psychiatric, infectious, neoplastic, or
metabolic disease

- No clinically significant malignant disease except nonmelanomatous skin cancer

- At least 1 year since any prior drug abuse or alcoholism

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

William S. Evans

Investigator Role:

Study Chair

Investigator Affiliation:

University of Virginia


United States: Federal Government

Study ID:




Start Date:

January 2000

Completion Date:

Related Keywords:

  • Polycystic Ovary Syndrome
  • Hyperinsulinism
  • endocrine disorders
  • hyperinsulinism
  • polycystic ovarian syndrome
  • rare disease
  • Hyperinsulinism
  • Polycystic Ovary Syndrome



Louisiana State University School of Medicine New Orleans, Louisiana  70112-2822
Washington University - St. Louis St. Louis, Missouri  63110
University of Virginia Charlottesville, Virginia  22908
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Medical College of Virginia School of Medicine Richmond, Virginia  23298-0230